Label Coordinator

Label Coordinator , Clinical Supplies

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

Currently we have an exciting opportunity for Label Coordinator within our Clinical Supplies team.

The role of Label Coordinator would provide support to clinical supplies operations and administrative activities in all areas of clinical supplies lifecycle of low to moderate complexity studies.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well-being of our employees.

Responsibilities: Ensures all activities are executed in compliance with company good practices and client requirements. Participates in and supports department project teams. May coordinate or serve as a liason cross-functionally. Plans and coordinates label, patient card and dosing card activities. Ensures label, patient card and dosing card activities are completed as needed according to PPD SOP requirements and/or client requirements. Coordinates the preparation and regulatory approval of information to be included on labels, patient cards and dosing cards in clinical trials. Reviews source documents and requests for quotes. Assists with the development and maintenance of the Global Labeling Management tool as per SOP-CS-38 and the Translation Glossary.

Qualifications:

Education and Experience:

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).

Knowledge, Skills and Abilities: Intermediate English and good communication skills both written and verbal Solid understanding of the Clinical Supply process, such as manufacturing, handling, importing, shipping, exporting, auditing, labeling and packaging Strong organizational, planning and time management skills planning analytical skills Good analytical skills and ability to work on issues of a diverse and confidential nature Proficient in Microsoft Office programs Strong customer service orientation and attention to detail aligned with high standards of quality and excellence Adaptive to changes and ability to handle high-pressure situations Ability to work in a team environment as well as work independently with moderate direct supervision Ability to utilize proper channels of communications to voice concerns and suggestions Management Role:

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we would love to hear from you.

Label Coordinator , Clinical Supplies

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. At PPD, we are passionate, deliberate, and driven by our purpose- to improve health!

Currently we have an exciting opportunity for Label Coordinator within our Clinical Supplies team.

The role of Label Coordinator would provide support to clinical supplies operations and administrative activities in all areas of clinical supplies lifecycle of low to moderate complexity studies.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well-being of our employees.

Responsibilities: Ensures all activities are executed in compliance with company good practices and client requirements. Participates in and supports department project teams. May coordinate or serve as a liason cross-functionally. Plans and coordinates label, patient card and dosing card activities. Ensures label, patient card and dosing card activities are completed as needed according to PPD SOP requirements and/or client requirements. Coordinates the preparation and regulatory approval of information to be included on labels, patient cards and dosing cards in clinical trials. Reviews source documents and requests for quotes. Assists with the development and maintenance of the Global Labeling Management tool as per SOP-CS-38 and the Translation Glossary.

Qualifications:

Education and Experience:

High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification Technical positions may require a certificate Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).

Knowledge, Skills and Abilities: Intermediate English and good communication skills both written and verbal Solid understanding of the Clinical Supply process, such as manufacturing, handling, importing, shipping, exporting, auditing, labeling and packaging Strong organizational, planning and time management skills planning analytical skills Good analytical skills and ability to work on issues of a diverse and confidential nature Proficient in Microsoft Office programs Strong customer service orientation and attention to detail aligned with high standards of quality and excellence Adaptive to changes and ability to handle high-pressure situations Ability to work in a team environment as well as work independently with moderate direct supervision Ability to utilize proper channels of communications to voice concerns and suggestions Management Role:

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are game changers - We do the right thing - We are one PPD

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we would love to hear from you.